MEDICAL ISSUES in human tissue lawsuits

At the heart of human tissue implant lawsuits are the following medical issues.

• No universal notification system. This means that there is no way to effectively notify patients in a timely manner.
  
• Letters from doctors vary. This means that there are no standards by which doctors will give notice to patients.
  
• Defendants control the flow of information. This means that there are no ways to ensure that the public receives any information, let alone the right information in a timely manner.
  

There are some laws that apply to medical tissues and the transplantation of these tissues:

21 CFR 8
PARTS 1251-1269 [RESERVED]
PART 1270 HUMAN TISSUE INTENDED FOR TRANSPLANTATION

Subpart A-General Provisions

Sec.1270.1 Scope.
1270.3 Definitions.

Subpart B-Donor Screening and Testing

1270.21 Determination of donor suitability for human tissue intended for transplantation.

Subpart C-Procedures and Records

1270.31 Written Procedures.
1270.33 Records, general requirements. (a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue. All records shall be accurate, indelible, and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved. (b) The frequency of inspection will be at the agency�s discretion.
1270.35 Specific records.

Subpart D-Inspection of Tissue Establishments

1270.41 Inspections
1270.42 Human tissue offered for import.
1270.43 Retention, recall, and destruction of human tissue.